Application of tDCS Stimulation in Controlling Refractory Status Epilepticus

Capital Medical University

Status: Enrolling

Conditions: Refractory Status Epilepticus

Treatments: Device: TDCS sham-stimulation; Device: tDCS stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06344338

Z211100002921030

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus

Full description

After being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation.

Enrollment: 32 estimated patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 14 and 80 year-old with Gender unlimited,
• Suitable for EEG monitoring;
• Clinical diagnosis of Refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic);
• Informed consent to participate in this study was obtained from the participants or their surrogates

Exclusion criteria

• Unstable vital signs (systolic blood pressure<90mmHg, heart rate<60 beats/min, pulse oxygen saturation<90%);
• Having severe skull injury/defect or medical equipment implanted in the head;
• Pregnancy;
• With any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

tDCS treatment group

Experimental group

Description:

In the real tDCS stimulation group, direct cathodal current at 2 mA was delivered by a tDCS device over the seizure onset zone. Anode was on the contralateral forehead. Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10.

Treatment:

Device: tDCS stimulation

TDCS sham-stimulation group

Sham Comparator group

Description:

The duration and frequency of tDCS treatments in the sham-stimulation group are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation.

Treatment:

Device: TDCS sham-stimulation